The case primarily concerns two patents for the diabetic medication Dapagliflozin.

a) Indian Patent No. 205147

b) Indian Patent No. 235625

The Delhi High Court has rejected AstraZeneca’s plea that two patents be granted for the same invention, one for the genus and the species.

Bristol Myers Squibb Company (“Bristol“) is the initially registered patent holder, as well as the grantee of these two patents. Bristol granted the inventions as mentioned earlier to Astra Sweden via an assignment document dated 01.02.2014.

Astra has obtained the mandatory statutory approvals for importing and marketing DAPA in India.

Let us discuss the issue?

The plaintiffs’ question was whether the compound-in-issue, Dapagliflozin [“DAPA”], covered by IN 147, is disclosed both in law and on facts?

Disputes on Genus and Species:

DAPA, according to Astra, is used to treat persons with type II diabetes mellitus all over the world. Markush structure, according to Astra, is a patent covering a collection of molecules that revealed the potentiality of individual permutations and combinations that can result in millions of structurally different compounds. IN 147, there is a Markush structure called genus patent claims, which has 22 variables. The results can be in millions, if not billions, of potential permutations and combinations.

While the plaintiffs’ Markush structure, as defined by its genus patent, IN 147, covers DAPA. This genus patent covers DAPA and is based on the commercialization of the medicine revealed in the species patent. As a result, this would not be an admission, as claimed, or at all. Thousands of patents may be covered by a single product. A cell phone was used as an example because it is the subject of several patents. The defendants should be refused injunction relief for the following reasons, according to Astra. Infringement is admitted since the defendants are either making or preparing to manufacture DAPA. DAPA is a manufactured medicine approved in 2020 for the treatment of hypertensive heart failure and type-II diabetes. Because the species patent is ancient and well-established, it comes with a presumption of validity, and this patent has been active for 18 years.

Technical details:

Section 25(1) of the Indian Patent Act (“Act“) gives the right to object to the award of a patent once an application for the same has been published. Subclauses (a) to (k) of Subsection (1) of Section 25 of the Act specify the reasons for filing an opposition. In general, Section 47 of the Act grants the patentee an exclusive right to exclude third parties from making [“act of using” in a process patent], using, offering for sale, selling, or importing that product [“that process” in the case of a process patent] in India for the purposes stated herein, as long as they do not have the patentee’s consent.

Section 64 of the Act grants the ability to revoke a patent. Thus, any individual interested [or the Central Government] can seek cancellation of a patent by submitting a counter-claim in an infringement suit brought before any high court or by petitioning the appellate board established under the Act. The fact that the plaintiffs have filed infringement actions for both IN 147 and IN 625 is a sufficient signal, at least at this point, that DAPA is claimed in both suit patents, according to the Court. The Court finds it incomprehensible that a patent holder can file an infringement case for a never disclosed patent.

The Indian genus patent, in this case, i.e. The priority dates for IN 147 are 12.10.1999 and 05.04.2000, respectively. However, the Indian species patent, i.e. The priority date for IN 625, is 20.05.2002. This element is sufficient for Section 64(1)(a).

Whereas the defendant can show that any claim of the whole specification [in this case IN 625] was a legitimate claim of an earlier priority date contained in the complete specification of another patent [i.e. A reason for revocation is established in [147]. By using these criteria, the plaintiffs’ assertions that DAPA was not claimed in IN 147 appear to be implausible at this point.

Even though the balance of convenience favours the plaintiffs, the Court concluded that the defendants have been able to mount a genuine challenge and prove, at least at the preliminary injunction stage, the fragility of the suit patents the injunction cannot be issued. If the plaintiffs had established a strong prima facie case for a preliminary injunction, they would still need to convince the Court that the balance of convenience was in their favour. That denial of interim relief would result in irreparable harm. In light of this, the Court considered the parties’ opposing arguments.

According to the claimants, the Indian genus patent, i.e. IN 147, was valid for its entire term. The Indian species patent, i.e. IN 625, is in its 18th year of existence.

Since 2015, the plaintiffs’ product has been sold in India at a fair price.

According to the plaintiffs, the defendants should be urged to “clear the way” as in Merck Sharp and Dohme Corporation and Ors. by following any of the following rules: vs Glenmark Pharmaceuticals, MANU/DE/0852/2015

  • Looking for a voluntary licence;
  • Obtaining a mandatory licence;
  • Filing revocations;
  • Filing a pre-grant and post-grant opposition; and 
  • Filing a non-infringement declaratory action.

Additionally, what has already been mentioned, the Court determined that the damages, in this case, appear to be compensable if proven at trial. The plaintiffs may have licenced their rights under the suit patents to two corporations, according to the defendants. Abbott and the Sun This is reflected in the packaging of the drug’s products supplied through these businesses.

On the other hand, the plaintiffs have not recorded the agreements reached with these entities to support their plea for reasons best known to them. As a result, it must be assumed that the entities mentioned above are licensees. Further, the plaintiffs claim to be importing their medicine into the country. As a result, the plaintiffs want to make money off of their invention. Thus, if they were to prevail at the end of the trial, they could be awarded damages provided the law allowed it.

The disparity in medicine pricing varies between 250 per cent and 350 per cent,” the Court continued. As a result, allowing defendants to manufacture and market their products would be significantly less expensive. Concerns about quality appear to be a self-serving argument at this point.”

Conclusion

The market for Dapagliflozin is estimated to be around Rs 360 crore and is developing at a rate of 29% per year. The Delhi High Court’s decision opens up a slew of new commercial options for generic brands and manufacturers in India, both those who have already released products and those planning to do so. (you may refer to it here for full judgment).

Disclaimer: The present article intends to provide general guidance on the subject, and you can also consult us in your specific case.

Authors

  • Title

    Madhura is an intellectual property professional. She also assists in article writing, editing, and proofreading for companies, businesses, start-ups and individuals. Madhura has extensive experience in Biotechnology, Genetic Engineering, Molecular Biology, Immunology, Biochemistry, and Biostatistics. She has graduated from the Department of Microbiology, Savitribai Phule Pune University – one of the premier institutes in the country for studying Life Sciences. She has completed various courses related to I.P. Law from different universities worldwide.

  • Title

    Abhishek is an intellectual property Attorney. He specializes in the registration and maintenance of patents, designs, trademarks, and copyrights. He regularly assists companies in relation to crucial technology issues. He also helps organizations or individuals to develop patent portfolio management strategies for exciting new inventions and processes. Abhishek has past work experience with reputed firms like SaiKrishna and Associates Advocates, L.S. Davar and Co., Masilamani Law Partners, and Ripple IP Services (NCR).